Topical oxygen therapy as a novel strategy to treat oral mucosal lesion.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome is the rate and extent of oral mucosal healing following the intervention, assessed through clinical evaluation of lesion size, tissue appearance, and symptom relief.Assessments will be conducted at baseline (Day 0), weekly during the initial 3 weeks, and then at 1, 3, 6, 9, and 12 months to monitor long-term healing, recurrence, and sustained treatment effectiveness.
研究概览
简要总结
oral mucosal lesions such as ulcers,traumatic injuries,and inflammatory conditions often impair oral function and quality of life.adequate oxygen supply is essential for epithelial regeneration and wound healing.this randomized controlled,open-label clinical trial aims to evaluate the efficacy and safety of topical oxygen therapy in enhancing the healing of oral mucosal lesions compared wit standard care.participants will receive either topical oxygen gel apply twice daily or conventional treatment.outcomes include clinical healing rate,reduction in pain,and improvement in lesion size over a 21-day period.the study seeks to establish topical oxygen therapy as a safe,non-invasive and effective adjunct in prompting oral mucosal repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 years and above.
- •Individuals presenting with clinically diagnosed recurrent aphthous stomatitis
- •Patients with no systemic conditions that may interfere with wound healing (e.g., uncontrolled diabetes, immunosuppressive disorders).
排除标准
- •Patients below 18 years of age.
- •Presence of systemic diseases that can impair wound healing (e.g., uncontrolled diabetes, immunodeficiency, autoimmune disorders).
- •Patients with any allergic, malignant or potentially malignant oral lesions.
- •Pregnant or lactating women.
结局指标
主要结局
The primary outcome is the rate and extent of oral mucosal healing following the intervention, assessed through clinical evaluation of lesion size, tissue appearance, and symptom relief.Assessments will be conducted at baseline (Day 0), weekly during the initial 3 weeks, and then at 1, 3, 6, 9, and 12 months to monitor long-term healing, recurrence, and sustained treatment effectiveness.
时间窗: Baseline (Day 0): Before starting the intervention Week 1 (Day 7): Early assessment of healing progress Week 2 (Day 14): Mid-point assessment Week 3 (Day 21): Final assessment of complete healing provide more details
次要结局
- Mean change in pain intensity (VAS 0–10)(% reduction in lesion surface area from baseline;)
研究者
J Nithya devi
Karpaga Vinayaga Institute of dental sciences